Methods of dispensing a urinary catheter from a sterile package

Abstract

A packaged closed intermittent urinary catheter system equipped with a dispensing system and method of dispensing a packaged catheter using the dispensing system. The dispensing system is a pair of separately translatable movement control devices, each operably engaging the catheter for permitting unidirectional movement of the catheter in a first axial direction relative to the movement control devices. The movement control devices may be mounted to a hand-grippable assembly with a sliding or pivoting movable member reciprocal to a base member. Alternatively, the movement control devices are mounted to a coupling member and a spring member biases them apart.

It is claimed: 
     
       1. A method of dispensing a catheter from a closed intermittent urinary catheter system, comprising:
 a) grasping a sterile flexible packaging defining a closed reservoir with an outlet opening, the reservoir defining an inner chamber that retains within a catheter defining a longitudinal axis and having a distal insertion tip positioned adjacent to and aimed toward the outlet opening, the reservoir further enclosing therein:
 i. first and second movement control devices each mounted around and in direct contact with the catheter, each movement control device having a locking member that moves to an unlocked position upon relative distal movement of the catheter therein to allow relative distal movement of the catheter, and moves to a locked position upon relative proximal movement of the catheter to prevent further relative proximal movement of the catheter, wherein the second movement control device is located between the distal insertion tip and the first movement control device, further comprising a latch in operable engagement with each locking member of the first and second movement control devices and manipulable from outside and through the flexible packaging, the latches configured to be actuated and hold the locking members of the first and second movement control devices in their unlocked positions, 
 
 b) manually manipulating the first and second movement control devices from outside the reservoir so as to displace them toward and away from one another and cause the catheter to be advanced distally through the outlet opening; 
 c) initiating insertion of the catheter into a urethra; 
 d) repeating the step of manually manipulating the first and second movement control devices until the catheter is inserted into a bladder; and 
 e) actuating and holding the locking members of the first and second movement control devices in their unlocked positions and relatively displacing the catheter through the first and second movement control devices in a proximal direction. 
 
     
     
       2. The method of  claim 1 , further comprising a handle grip that includes (i) a hand graspable base member fixedly attached to the second movement control device, and (ii) a movable member reciprocally engaged to the base member and fixedly attached to the first movement control device, wherein reciprocation of the movable member relative to the base member causes relative displacement of the first and second movement control devices. 
     
     
       3. The method of  claim 2 , wherein the flexible packaging is a plastic bag and the base member is attached to the bag, wherein a first portion of the base member is disposed inside the bag and a second portion of the base member is disposed outside the bag, and whereby a passageway through the second portion of the base member defines the outlet opening, and wherein the movable member is slidably disposed for reciprocal movement in a distal-proximal direction within a channel in the base member, the movable member including a finger pad facing toward the bag that is manually manipulable from outside and through the bag, the finger pad having a flat surface. 
     
     
       4. The method of  claim 2 , wherein the movable member is formed integrally with the base member and pivotally disposed for reciprocal movement in a distal-proximal direction within a channel in the base member through which the catheter passes, and the step of manually manipulating the first and second movement control devices from outside the reservoir comprises repeatedly pivoting the movable member in opposite directions. 
     
     
       5. The method of  claim 1 , wherein:
 a) each movement control device comprises (i) a main body having a passageway defining a central axis, and (ii) the locking member hingedly attached to the main body for pivoting about a pivot axis and having an orifice defining a central axis extending therethrough, (iii) whereby the locking member is pivotable between the unlocked position wherein the central axis of the orifice is aligned with the central axis of the passageway and permits distal movement of the catheter relative to the movement control device, and the locked position wherein the central axis of the orifice is misaligned with the central axis of the passageway and resists proximal movement of the catheter relative to the movement control device, and 
 b) the catheter extends through the passageway and the orifice in both of the movement control devices. 
 
     
     
       6. The method of  claim 1 , further including a third movement control device disposed at and attached to one end of the flexible packaging just inside the outlet opening, the third movement control device having a locking element that is biased to a locked position that prevents relative distal movement of the catheter through the third movement control device, and wherein the outlet opening of the flexible packaging has an introducer tip sized to fit within the outer end of a urethra of the user and made of a flexible elastomer which has petals that the catheter spreads apart upon distal passage therethrough, and the packaging is collapsible at the outlet opening, the method including applying pressure on the introducer tip from the urethra to collapse the packaging and move the locking element from the locked position to an unlocked position that allows relative distal movement of the catheter through the third movement control device. 
     
     
       7. A method of dispensing a catheter from a closed intermittent urinary catheter system, comprising:
 a) grasping a sterile flexible packaging defining a closed reservoir with an outlet opening, the reservoir defining an inner chamber that retains within a catheter defining an insertion end, a fixture end and a longitudinal axis, the reservoir further enclosing therein:
 i. first and second longitudinally separated movement control devices, each in direct contact with and operably engaging the catheter for causing unidirectional movement of the catheter in a first axial direction relative to the movement control devices upon coordinated movement of the movement control devices, wherein the first and second movement control devices are integrally formed in one piece along with a coupling member that connects the movement control devices and has a spring member configured to bias the movement control devices apart, and the steps of pushing and pulling the first and second movement control devices towards and away from one another comprises repeatedly squeezing and releasing the coupling member, 
 
 b) pushing the first and second movement control devices towards one another along the longitudinal axis of the catheter to cause longitudinal translation of the second movement control device in a second axial direction opposite the first axial direction relative to the catheter with inconsequential longitudinal translation of the first movement control device relative to the catheter to effect dispensing of the catheter in the first axial direction from the packaging; 
 c) pulling the first and second movement control devices away from one another along the longitudinal axis of the catheter to cause longitudinal translation of the first movement control device in the second axial direction relative to the catheter with inconsequential longitudinal translation of the second movement control device relative to the catheter; 
 d) initiating insertion of the catheter into a urethra; and 
 e) repeating the steps of pulling apart and pushing together the movement control devices until the catheter is inserted into a bladder. 
 
     
     
       8. The method of  claim 7 , wherein the coupling member is a resilient strip that forms the spring member. 
     
     
       9. A method of dispensing a catheter from a closed intermittent urinary catheter system, comprising:
 a) grasping a sterile flexible packaging defining a closed reservoir with an outlet opening, the reservoir defining an inner chamber that retains within a catheter defining a longitudinal axis and having a distal insertion tip positioned adjacent to and aimed toward the outlet opening, the reservoir further enclosing therein:
 i. first and second movement control devices each mounted around and in direct contact with the catheter, each movement control device having a locking member that moves to an unlocked position upon relative distal movement of the catheter therein to allow relative distal movement of the catheter, and moves to a locked position upon relative proximal movement of the catheter to prevent further relative proximal movement of the catheter, wherein the second movement control device is located between the distal insertion tip and the first movement control device, and 
 ii. a handle grip that includes (i) a hand graspable base member fixedly attached to the second movement control device, and (ii) a movable member reciprocally engaged to the base member and fixedly attached to the first movement control device, wherein reciprocation of the movable member relative to the base member causes relative displacement of the first and second movement control devices, 
 
 b) manually manipulating the first and second movement control devices from outside the reservoir so as to displace them toward and away from one another and cause the catheter to be advanced distally through the outlet opening; 
 c) initiating insertion of the catheter into a urethra; and 
 d) repeating the step of manually manipulating the first and second movement control devices until the catheter is inserted into a bladder. 
 
     
     
       10. The method of  claim 9 , wherein the flexible packaging is a plastic bag and the base member is attached to the bag, wherein a first portion of the base member is disposed inside the bag and a second portion of the base member is disposed outside the bag, and whereby a passageway through the second portion of the base member defines the outlet opening, and wherein the movable member is slidably disposed for reciprocal movement in a distal-proximal direction within a channel in the base member, the movable member including a finger pad facing toward the bag that is manually manipulable from outside and through the bag, the finger pad having a flat surface. 
     
     
       11. The method of  claim 9 , wherein the movable member is formed integrally with the base member and pivotally disposed for reciprocal movement in a distal-proximal direction within a channel in the base member through which the catheter passes, and the step of manually manipulating the first and second movement control devices from outside the reservoir comprises repeatedly pivoting the movable member in opposite directions. 
     
     
       12. A method of dispensing a catheter from a closed intermittent urinary catheter system, comprising:
 a) grasping a sterile flexible packaging defining a closed reservoir with an outlet opening, the reservoir defining an inner chamber that retains within a catheter defining an insertion end, a fixture end and a longitudinal axis, the reservoir further enclosing therein:
 i. first and second longitudinally separated movement control devices, each in direct contact with and operably engaging the catheter for causing unidirectional movement of the catheter in a first axial direction relative to the movement control devices upon coordinated movement of the movement control devices, and 
 ii. a handle grip that includes at least (i) a hand graspable casing fixedly attached to one of the movement control devices, and (ii) a finger actuable button reciprocally engaged to the casing and fixedly attached to the other movement control device, the method including reciprocation of the button relative to the casing to cause the pulling apart and pushing together of the movement control devices along the catheter; 
 
 b) pushing the first and second movement control devices towards one another along the longitudinal axis of the catheter to cause longitudinal translation of the second movement control device in a second axial direction opposite the first axial direction relative to the catheter with inconsequential longitudinal translation of the first movement control device relative to the catheter to effect dispensing of the catheter in the first axial direction from the packaging; 
 c) pulling the first and second movement control devices away from one another along the longitudinal axis of the catheter to cause longitudinal translation of the first movement control device in the second axial direction relative to the catheter with inconsequential longitudinal translation of the second movement control device relative to the catheter; 
 d) initiating insertion of the catheter into a urethra; and 
 e) repeating the steps of pulling apart and pushing together the movement control devices until the catheter is inserted into a bladder. 
 
     
     
       13. A method of dispensing a catheter from a closed intermittent urinary catheter system, comprising:
 a) grasping a sterile flexible packaging defining a closed reservoir with an outlet opening, the reservoir defining an inner chamber that retains within a catheter defining an insertion end, a fixture end and a longitudinal axis, the reservoir further enclosing therein:
 i. first and second longitudinally separated movement control devices, each in direct contact with and operably engaging the catheter for causing unidirectional movement of the catheter in a first axial direction relative to the movement control devices upon coordinated movement of the movement control devices, and 
 ii. a handle grip that includes (i) a hand graspable base member fixedly attached to the second movement control device, and (ii) a movable member reciprocally engaged to the base member and fixedly attached to the first movement control device, wherein the movable member is formed integrally with the base member and pivotally disposed for reciprocal movement in a distal-proximal direction within a channel in the base member through which the catheter passes, and the steps of pushing and pulling the first and second movement control devices towards and away from one another comprises repeatedly pivoting the movable member in opposite directions; 
 
 b) pushing the first and second movement control devices towards one another along the longitudinal axis of the catheter to cause longitudinal translation of the second movement control device in a second axial direction opposite the first axial direction relative to the catheter with inconsequential longitudinal translation of the first movement control device relative to the catheter to effect dispensing of the catheter in the first axial direction from the packaging; 
 c) pulling the first and second movement control devices away from one another along the longitudinal axis of the catheter to cause longitudinal translation of the first movement control device in the second axial direction relative to the catheter with inconsequential longitudinal translation of the second movement control device relative to the catheter; 
 d) initiating insertion of the catheter into a urethra; and 
 e) repeating the steps of pulling apart and pushing together the movement control devices until the catheter is inserted into a bladder. 
 
     
     
       14. A method of dispensing a catheter from a closed intermittent urinary catheter system, comprising:
 a) grasping a sterile flexible packaging defining a closed reservoir with an outlet opening, the reservoir defining an inner chamber that retains within a catheter defining an insertion end, a fixture end and a longitudinal axis, the reservoir further enclosing therein:
 i. first and second longitudinally separated movement control devices, each in direct contact with and operably engaging the catheter for causing unidirectional movement of the catheter in a first axial direction relative to the movement control devices upon coordinated movement of the movement control devices, and 
 ii. wherein the first and second movement control devices are separately inserted into a compressible coupling member that connects the movement control devices and has a separate coil spring arranged around the coupling member configured to bias the movement control devices apart, and the steps of pushing and pulling the first and second movement control devices towards and away from one another comprises repeatedly squeezing and releasing the coupling member; 
 
 b) pushing the first and second movement control devices towards one another along the longitudinal axis of the catheter to cause longitudinal translation of the second movement control device in a second axial direction opposite the first axial direction relative to the catheter with inconsequential longitudinal translation of the first movement control device relative to the catheter to effect dispensing of the catheter in the first axial direction from the packaging; 
 c) pulling the first and second movement control devices away from one another along the longitudinal axis of the catheter to cause longitudinal translation of the first movement control device in the second axial direction relative to the catheter with inconsequential longitudinal translation of the second movement control device relative to the catheter; 
 d) initiating insertion of the catheter into a urethra; and 
 e) repeating the steps of pulling apart and pushing together the movement control devices until the catheter is inserted into a bladder.